Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis
Purpose
Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis
Condition
- Multiple Sclerosis (MS)
Eligibility
- Eligible Ages
- Between 10 Years and 17 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Between 10 to <18 years of age (i.e., have not yet had their 18th birthday) at randomization 2. Diagnosis of multiple sclerosis 3. EDSS score of 0 to 5.5, inclusive 4. At least one MS relapse/attack during the previous year or two MS relapses in the previous two years prior or evidence of one or more new T2 lesions within 12 months
Exclusion Criteria
- Participants with progressive MS 2. Participants with an active, chronic disease of the immune system other than MS 3. Participants meeting the definition of ADEM 4. Participants with severe cardiac disease or significant findings on the screening ECG. 5. Participants with severe renal insufficiency
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- The core part of the study and the first 12 weeks of the extension period (transition) will be double-blinded and the remainder of the extension period will be open label.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental ofatumumab - 20 mg injection/ placebo |
Ofatumumab as a solution for injection in an autoinjector containing 20 mg ofatumumab (50 mg/mL, 0.4 mL content) for subcutaneous administration. A loading dose at Day1, Day 7 and Day 14 and then injections every 4 weeks/ 6 weeks (depending on patient's body weight). |
|
|
Experimental siponimod - 0.5 mg, 1 mg or 2 mg/ placebo |
Siponimod tablet administered orally once daily. Titration period, Day 1 to Day 6, first dose is either 0.1 mg or 0.25 mg up to daily dose of either 0.5 mg, 1 mg or 2 mg (depending on CYP2C9 genotype and body weight). |
|
|
Active Comparator fingolimod - 0.5 mg or 0.25 mg/ placebo |
Fingolimod capsule administered orally once daily at a dose of either 0.5 mg or 0.25 mg (depending on patient's body weight). |
|
Recruiting Locations
Children's National and nearby locations
Washington, District of Columbia 20010
More Details
- NCT ID
- NCT04926818
- Status
- Recruiting
- Sponsor
- Novartis Pharmaceuticals
Detailed Description
The study is divided into a Core Part and Extension Part. The Core Part is a 24-month, double-blind, triple dummy, randomized, 3-arm active-controlled in children/adolescent patients aged 10-17 years old with Multiple Sclerosis (MS). The Extension Part is 60-month (5 year) open label (except for first 12 weeks transition which will remain double-blind) treatment for patients who complete the Core Part of the study and meet all inclusion/exclusion criteria. The targeted enrollment is 120 participants with multiple sclerosis which will include at least 5 participants with body weight (BW) ≤40 kg and at least 5 participants with age 10 to 12 years in each of the ofatumumab and siponimod arms. There is a minimum 6 month follow up period for all participants (core and extension). Total duration of the study could be up to 7 years.